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Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02697773
First received: February 11, 2016
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.

Condition Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Other: Placebo
Biological: Tanezumab 2.5 mg
Biological: Tanezumab 2.5mg/5mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of A Dose Titration Regimen For The Subcutaneous Administration Of Tanezumab In Subjects With Osteoarthritis Of The Hip Or Knee

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • WOMAC Pain-Change from Baseline to Week 16 [ Time Frame: Week 16 ]
  • WOMAC Physical Function-Change from Baseline to Week 16 [ Time Frame: Week 16 ]
  • Patient's Global Assessment of Osteoarthritis (PGA)-Change from Baseline to Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • WOMAC pain, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 24 ]
  • Patient's global assessment of osteoarthritis, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 24 ]
  • OMERACT-OARSI responder index [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Treatment Response (WOMAC Pain), incidence of subjects with 30, 50, 70, 90% improvement [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Average pain score in the index joint, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • WOMAC stiffness, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • WOMAC average, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Work Productivity and Activity Impairment (WPAI):OA scores [ Time Frame: Bsl, Week 16 ]
  • EuroQol 5 Dimensions and overall health utility score [ Time Frame: Bsl, Weeks 8 and 16 ]
  • Discontinuation from the study due to lack of efficacy, incidence [ Time Frame: Up to week 16 ]
  • Incidence of rescue medication use [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • WOMAC Physical Function, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 24 ]
  • WOMAC pain when walking on a flat surface, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • WOMAC pain when going up and down the stairs, change from baseline [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Treatment response (PGA), incidence of subjects with 2 point improvement [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score to Week 16 (endpoint for summary only) [ Time Frame: Week 16 ]
  • Health Care Research Utilization questionnaire - summary of findings [ Time Frame: Baseline, Weeks 24, 40 ]
  • Incidence of Adverse Events [ Time Frame: up to Week 40 ]
  • Incidence of protocol-specified adjudication outcomes [ Time Frame: up to Week 40 ]
  • Incidence of Total joint replacements [ Time Frame: up to Week 40 ]
  • Neurological Impairment Score [ Time Frame: Bsl, Weeks 2, 4, 8, 12, 16, 24, 40 ]
  • Orthostatic Blood Pressure measurements [ Time Frame: Bsl, Weeks 2, 4, 8, 12, 16, 24, 40 ]
  • Survey of Autonomic Symptoms Scores [ Time Frame: Bsl, Weeks 24 and 40 ]
  • Anti-drug antibodies, incidence [ Time Frame: Bsl, Weeks 8, 16, 24, 40 ]
  • General Physical examination [ Time Frame: up to week 16 ]
    clinically significant changes will be reported as adverse events and summarized with the adverse events

  • Incidence of Subjects with Clinical Laboratory Test Abnormalities (hematology, chemistry) [ Time Frame: Bsl, Week 24 ]
  • Summary of ECG parameters [ Time Frame: Bsl, Weeks 16, 40 ]
    Standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals and HR)Max 999 Characters...

  • Musculoskeletal-specific Physical Examination, incidence of findings [ Time Frame: up to week 40 ]
  • Rescue Medication, total amount used [ Time Frame: Bsl, Weeks 2, 4, 8, 12, 16, 24 ]
  • Time to withdrawal from the study due to lack of efficacy [ Time Frame: Up to week 16 ]
  • Rescue Medication, number of days of use [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ]
  • Sitting vital signs (blood pressure) [ Time Frame: Bsl, Weeks 2, 4, 8, 12, 16, 24, 40 ]
  • Sitting vital signs (heart rate) [ Time Frame: Bsl, Weeks 2, 4, 8, 12, 16, 24, 40 ]

Estimated Enrollment: 690
Actual Study Start Date: January 21, 2016
Estimated Study Completion Date: April 6, 2018
Estimated Primary Completion Date: October 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo administered subcutaneously at day 0 and week 8
Other: Placebo
Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
Experimental: Tanezumab 2.5 mg
tanezumab 2.5 mg administered subcutaneously at day 0 and week 8
Biological: Tanezumab 2.5 mg
Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
Experimental: Tanezumab 2.5mg/5mg
tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8
Biological: Tanezumab 2.5mg/5mg
Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
Other Name: Titration Arm

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
  • Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
  • Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
  • Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
  • Women able to have children must agree to use 2 forms of contraception during the study

Exclusion Criteria:

  • Body Mass Index (BMI) greater than 39
  • History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
  • Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
  • Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
  • Planned surgical procedure during the study
  • Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care)
  • Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary
  • Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
  • Patients with significant heart, neurological or psychiatric diseases
  • Patients who had cancer other than certain skin cancers within the past 5 years
  • Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
  • Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02697773

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 96 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02697773     History of Changes
Other Study ID Numbers: A4091056
2013-002222-23 ( EudraCT Number )
OA TITRATION STUDY ( Other Identifier: Alias Study Number )
Study First Received: February 11, 2016
Last Updated: April 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
osteoarthritis of the knee
osteoarthritis of the hip
nerve growth factor inhibitor
tanezumab

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 27, 2017